Local public health entities obtain FDA consent to carry out faster COVID-19 diagnoses
By Pedro Correa Henry
Special to The Star
The island Health Department (DS by its Spanish initials) and the Puerto Rico Science, Technology and Research Trust (PRSTRT) on Wednesday announced the creation of the Puerto Rico Diagnostic Test Evaluation Commission (PRoDTEC) to increase capacity and efficiency in diagnosing COVID-19 amid the public health emergency.
After obtaining the U.S. Food and Drug Administration’s (FDA) consent to grant emergency use authorizations for tests that detect SARS-CoV-2 in laboratories, the two local entities determined to create a commission composed of a panel of experts that will review and approve with greater agility the use of diagnostic tests on the island for the detection of the SARS-CoV-2 virus, which causes COVID-19.
Health Secretary Lorenzo González Feliciano said the commission will evaluate the validity of as well as stimulate the development of new diagnostic methodologies and tests for the detection of the novel coronavirus.
“This effort demonstrates the collaboration that exists between entities and people who want to work for the sake of Puerto Rico,” González Feliciano said. “The Trust is like a sibling to the [Health] Department, and vice versa; what matters is that we joined forces to fight against COVID-19. This effort, where the Trust [and its commission] can opt to analyze tests and authorize them locally, gives us great scientific autonomy.”
The Health secretary said further that the determination, which he called a “cutting edge initiative,” makes the island join states such as Connecticut, Maryland, Mississippi, Nevada, New Jersey, New York and Washington, which have also received the FDA’s consent to carry out an evaluation under the federal agency’s guidelines and in-house scientific rigor. He said PRoDTEC is also an important step for the scientific community because it serves as a basis for speeding up the implementation of new science-based diagnostic methods for other emerging infectious diseases in the future.
PRSTRT Trustee Daniel Colón Ramos said meanwhile that, as both a Puerto Rican citizen and scientist, he regards PRoDTEC as an important measure for the island as it gives scientists the power to collaborate actively with the FDA in terms of the tests that will be evaluated and, if authorized, used to diagnose the coronavirus disease. Colón Ramos, who is also the president of the Scientific Committee appointed to manage the creation of the PRoDTEC, said the Health secretary delegated them “without restrictions, but with the clear task of using rigorous criteria in the selection of candidates to form part of the Commission.” The committee reviewed half a dozen competing nominations and unanimously selected Puerto Rico Public Health Trust Research Manager Marcos López Casillas, Business Excellence Consulting Senior Quality Systems Consultant Agnes Rodríguez Soto, and MBQ Pharma CEO Federico Goodsaid Zalduondo as voting members of PRoDTEC.
“We are not one-armed; we have the scientific capability and we are at the midst of a pandemic where no one in the world holds the answers,” Colón Ramos said. “The scientific community is gathering its best resources and knowledge to tackle this pandemic. It brings me hope to see both the DS and PRSTRT collaborate as, I, a scientist, believe that, literally, lives will be saved.”
Colón Ramos added that he hopes the creation of PRoDTEC will lead the island to conduct more COVID-19 tests and surpass the July numbers, when some 4,500-6,000 molecular tests were performed daily.
PRoDTEC will first submit a protocol for expedited evaluation of COVID-19 diagnostic tests for approval by the Health Department. Then it will collaborate with the COVID-19 Clinical Laboratory Working Group to establish the protocol in Clinical Laboratory Improvement Amendments-certified laboratories that meet the regulatory requirements to perform highly complex tests.